Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01491633
Eligibility Criteria:
Inclusion Criteria:
* Stage III/B or IV squamous NSCLC
* Measurable disease
* Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
* ECOG performance status of 0 or 1
* Estimated life expectancy greater than 12 weeks
* Normal organ and marrow function
* Confirmed availability of archival pathology samples
* Agrees to discontinue St. Johns Wort
* Able to take medications by mouth
* Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug
Exclusion Criteria:
* Pregnant or breast-feeding
* Chemotherapy or radiotherapy within 4 weeks prior to entering study
* Receiving any other investigational agents
* Known untreated or progressive brain metastases
* History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
* Taking medications known to be potent CYP3A4 inhibitors
* Currently taking H2 inhibitors or proton pump inhibitors
* Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
* HIV positive
* Clinically uncontrolled hypertension (blood pressure \> 160/110)
* Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
* Active and uncontrolled clinically significant infection
* Chronic gastrointestinal disease
* Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
* Supplemental oxygen required for current malignancy
* Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
* Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01491633
Study Brief:
Protocol Section:
NCT01491633